Overview
Como parte de Consultoría de Parexel, cumplirá un rol vital al asistir a las empresas biofarmacéuticas y de dispositivos médicos a transitar el complejo y siempre cambiante entorno regulatorio. Respaldado por su experiencia científica, técnica y regulatoria, trabajará de cerca con los clientes para desarrollar e implementar estrategias regulatorias que colocarán sus medicamentos en el mercado con mayor rapidez y los mantendrán allí.
Valoramos la colaboración, la innovación y el aprendizaje continuo. Como miembro de nuestro equipo, se asociará con un grupo diverso de clientes y estará expuesto a diversos tipos de medicamentos y áreas terapéuticas. Asimismo, desarrollará sus habilidades a través de asignaciones desafiantes y con la mentoría de profesionales experimentados en asuntos regulatorios. Además, disfrutará de la flexibilidad de trabajar en modalidad remota, al tiempo que forma parte de un equipo colaborador y dinámico.
Perfil del éxito
¿Posee estas competencias sociales y rasgos interpersonales para tener éxito en Parexel?
- Comunicador
- Estratégico
- Constructor de relaciones
- Solucionador de problemas
- Orientado al detalle
- Impulsado por los resultados
Acerca de este rol
About this role:
The Associate contributes statistical capabilities and methodological support at all stages of projects, from planning to completion. The role would work under the supervision on an experienced team member in designing, developing, and delivering client solutions across multiple projects – leveraging competencies in statistical theory, data analysis and interpretation, regression analysis, and experimental design.
Knowledge and Experience Required for this role:
-Familiarity with healthcare consulting or pharmaceutical organizations. Strong basis in fundamental statistical concepts and methods and familiarity with techniques such as development of predictive equations, survival analysis (including parametric methods), longitudinal data analysis, meta-analysis, mixed treatment comparison, and other hierarchical analysis techniques, etc.
Familiarity with machine learning techniques and Bayesian statistics is a plus.
Strong statistical programming skills with standard software.
Education:
Master or higher degree in Public Health, Health Economics, Health Policy, Statistics, Biostatics, Mathematics, or other quantitative fields.
Skills:
Ability to work under pressure to meet multiple and sometimes competing deadlines.
Excellent scientific, business writing, and presentation skills with close attention to detail.
Exceptional communication skills, especially in the relaying of technical information and project concepts.
Competent in written and spoken English SAS, R, SQL, or Python
Strong communication (spoken and written) and problem-solving skills, and an ability to learn-quickly.
Ability to communicate effectively, in non-technical terms, with project team members.
Ability to work well in a team as well as independently and be able to take leadership role with regard to methodological elements in projects.
Job Description
Key Accountabilities:
Project Execution
Acting as support biostatistician or statistical programmer to interact with the study team and the sponsor
Support in drafting statistical sections of protocols, performing sample size and power calculation for studies.
Supporting in reviewing data management plans, data specifications, and other related study documents
Supporting in developing statistical analysis plans
Contributing to the preparation of specifications for analysis datasets
Supporting in developing statistical programs to generate listings, tables and figures as outlined by a statistical analysis plan
Performing QC of TLFs and other analysis datasets
Reviewing study protocols and providing input to statistics section
Providing statistical input to Clinical Study Reports
To help ensure quality standards are adhered to on all projects and new methodologies and techniques are adequately assessed and implemented.
To help foster thought leadership opportunities.
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